ABSTRACT
Prepackaged sterile medical devices and supplies became necessary in the late 1960s with the growth in prepaid health insurance programs. Insurers required that health care providers itemize the cost of all the supplies used during a procedure. This led to the rapid growth in the development of disposable or single-use devices. These were packaged in paper/plastic pouches, trays, or containers and then sterilized. At the time of use, the package was torn open to expose the sterile device. When the package was torn, the device was showered with particulates and bacteria that caused a great deal of concern. At that time, the medical device industry was not regulated by the U.S. Food and Drug Administration (FDA).
